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Latest From Opexa Therapeutics, Inc.
Scrip Asks…What Does 2022 Hold For Biopharma? Part 4: Therapeutic Area Advances
Evolving challenges will keep the COVID-19 pipeline active, while oncology, immunology and CNS are areas also expected to see much progress in 2022. Industry executives look forward to the year in therapeutic R&D.
Finance Watch: Days Of Reckoning As Biopharma Valuations, Fundraising Opportunities Fluctuate
Biotech stock indices have seen a recent recovery but remain well below their 2021 peaks raising questions about the likelihood of raising money for R&D. The number of companies announcing leadership changes, shifting pipeline priorities and job cuts is rising as a result.
US FDA GMP Warnings To OTC Firms In China, South Korea
Cosmo Bio's response to remote records request shows the South Korea company was marketing an unapproved OTC acne treatment without adequate release or stability testing. In China, Hubei Kangzheng was manufacturing an ophthalmic in a Grade D area without appropriate microbial controls.
The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations
US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.